APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)
Public ClinicalTrials.gov record NCT03745716. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Multicenter, Randomized, Open Label Study of APR-246 in Combination With Azacitidine Versus Azacitidine Alone for the Treatment of (Tumor Protein) TP53 Mutant Myelodysplastic Syndromes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.
Study identification
- NCT ID
- NCT03745716
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 154 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 10, 2019
- Primary completion
- Nov 26, 2020
- Completion
- Jan 13, 2022
- Last update posted
- Mar 17, 2025
2019 – 2022
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| Stanford University Cancer Research Center | Palo Alto | California | 94304 | — |
| Yale Cancer Center | New Haven | Connecticut | 06510 | — |
| Memorial Health Care System South Florida | Hollywood | Florida | 33021 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Moffitt Cancer Center | Tampa | Florida | 12902 | — |
| Robert H Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | 60611 | — |
| University Of Chicago Medicine | Chicago | Illinois | 60637 | — |
| University of Iowa Hospitals and Clinics, Holden Cancer Center | Iowa City | Iowa | 52242 | — |
| Ochsner Cancer Institute | New Orleans | Louisiana | 70121 | — |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | — |
| Washington University St. Louis | St Louis | Missouri | 63130 | — |
| Cornell Medical Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center, Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 19023 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03745716, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2025 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03745716 live on ClinicalTrials.gov.